pWRG/HTN-M(co)/pWRG/PUUV-M(United States Army Medical Research and Materiel Command)(pWRG/HTN-M(co)/pWRG/PUUV-M(United States Army Medical Research and Materiel Command))

概要

基本信息

药物类型

DNA疫苗、预防性疫苗

别名

HTNV/PUU DNA vaccine、HTNV/PUUV DNA vaccine、Hantaan virus/puumala virus DNA vaccine

+ [7]

靶点

汉坦病毒M蛋白

作用方式

抑制剂

作用机制

汉坦病毒M蛋白抑制剂

治疗领域

感染

在研适应症

病毒性出血热

非在研适应症

肾综合征出血热

原研机构

United States Army Medical Research and Materiel Command

在研机构

Ichor Medical Systems, Inc.

United States Army Medical Research and Materiel Command

非在研机构-

最高研发阶段临床2期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

2

项与 pWRG/HTN-M(co)/pWRG/PUUV-M(United States Army Medical Research and Materiel Command) 相关的临床试验

NCT02116205

/ Completed临床2期IIT

A Phase 2a Double-Blind, Dose-optimizing Study to Evaluate the Immunogenicity of Hantaan/Puumala Virus DNA Vaccine Administered to Healthy Adult Volunteers by Electroporation for Prevention of Hemorrhagic Fever With Renal Syndrome

The purpose of this study is to compare the immune responses of two different doses (1.0 mg and 2.0 mg) and two different dosing schedules (two doses or three doses) of a mixed Hantaan virus (HTNV) and Puumala virus (PUUV) DNA vaccine in healthy participants. To maintain a blind, participants in the two-dose group will receive one dose of normal saline placebo. All of the groups will also receive a booster dose 6 months after first vaccination. The results will help to determine which dose and vaccination schedule will be best to move forward in the vaccine development process.

开始日期2014-07-09

申办/合作机构

U S Army Medical Research & Development Command

[+4]

NCT01502345

/ Completed临床1期IIT

Phase 1 Study to Evaluate the Safety, Tolerability, and Immunogenicity of Hantaan and Puumala Virus DNA Vaccines, pWRG/HTN-M(x) and pWRG/PUU-M(s2), for Prevention of Hemorrhagic Fever With Renal Syndrome Administered to Healthy Adult Volunteers Using the TDS-IM Electroporation Delivery Device

The purpose of this study is:
• To assess safety and tolerability of the HTNV and PUUV DNA vaccines, pWRG/HTN-M(x) and pWRG/PUUV-M(s2), administered intramuscularly using a TDS-IM electroporation device
Secondary:
• To evaluate clinical immunogenicity of the HTNV and PUUV DNA vaccines, pWRG/HTN-M(x) and pWRG/PUUV-M(s2), including an assessment of the acute procedure tolerability when administered with the TDS-IM electroporation.

开始日期2012-01-01

申办/合作机构

U S Army Medical Research & Development Command

[+4]

100 项与 pWRG/HTN-M(co)/pWRG/PUUV-M(United States Army Medical Research and Materiel Command) 相关的临床结果

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100 项与 pWRG/HTN-M(co)/pWRG/PUUV-M(United States Army Medical Research and Materiel Command) 相关的转化医学

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100 项与 pWRG/HTN-M(co)/pWRG/PUUV-M(United States Army Medical Research and Materiel Command) 相关的专利（医药）

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1

项与 pWRG/HTN-M(co)/pWRG/PUUV-M(United States Army Medical Research and Materiel Command) 相关的文献（医药）

Vaccines3区 · 医学

A Phase 2a Randomized, Double-Blind, Dose-Optimizing Study to Evaluate the Immunogenicity and Safety of a Bivalent DNA Vaccine for Hemorrhagic Fever with Renal Syndrome Delivered by Intramuscular Electroporation

3区 · 医学

ArticleOA

作者: Kwilas, S ; Norris, S ; Josleyn, M ; Hill, B ; Paolino, K M ; Wisniewski, M ; Cohen, M ; Schmaljohn, C S ; Hannaman, D ; Sanchez-Lockhart, M ; Hooper, Jay ; Mills, K ; Somerville, B

Hantaan virus (HTNV) and Puumala virus (PUUV) are pathogenic hantaviruses found in Asia and Europe, respectively. DNA vaccines targeting the envelope glycoproteins of these viruses have been constructed and found to elicit neutralizing antibodies when delivered to humans by various technologies including intramuscular electroporation. Here, we report findings from a Phase 2a clinical trial of a combined HTNV/PUUV DNA vaccine delivered at varying doses and administration schedules using the Ichor Medical Systems TriGrid intramuscular electroporation delivery technology. The study was designed to characterize the effects of DNA vaccine dose and number of administrations on the frequency and magnitude of immunological response. Subjects (n = 120) were divided into four cohorts. Cohorts 1 and 2 received a dose of 2 mg of DNA (1 mg per plasmid), and cohorts 3 and 4 received a dose of 1 mg of DNA (0.5 mg per plasmid) each vaccination. Each of the four cohorts received a series of four administrations (days 0, 28, 56 and 168). For cohorts 1 and 3, the DNA vaccine candidate was delivered at each of the four administrations. For cohorts 2 and 4, in order to maintain blinding, subjects received the DNA vaccine on days 0, 56 and 168, but on day 28 received only the phosphate buffered saline vehicle rather the DNA vaccine. Sera were collected on days 0, 28, 56, 84, 140, 168, 196, 252 and 365 and evaluated for the presence of neutralizing antibodies by PUUV and HTNV pseudovirion neutralization assays (PsVNAs). Day 84 was also evaluated by a plaque reduction neutralization test (PRNT). Overall the PsVNA50 geometric mean titers (GMTs) and seropositivity rates among cohorts were similar. Cohort 3 exhibited the highest frequency of subjects that became seropositive to both PUUV and HTNV after vaccination, the highest peak GMT against both viruses, and the highest median titers against both viruses.

100 项与 pWRG/HTN-M(co)/pWRG/PUUV-M(United States Army Medical Research and Materiel Command) 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
病毒性出血热	临床2期	-	Ichor Medical Systems, Inc.	-
病毒性出血热	临床2期	-	United States Army Medical Research and Materiel Command	-
肾综合征出血热	药物发现	美国	Ichor Medical Systems, Inc.	2012-01-01

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临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02116205 (CTgov)	临床2期	肾综合征出血热	130	Placebo+HTNV/PUUV DNA vaccine (Vaccine + Placebo at 1.0 mg)	膚積鏇醖構顧簾鏇夢構(衊艱餘簾築選積壓壓選) = 窪鑰製糧襯餘衊觸窪繭築獵網鹽艱廠壓選膚廠 (膚艱積齋範積蓋獵窪獵, 膚壓觸鏇鬱獵製齋鏇蓋 ~ 選鹹遞餘衊構觸獵壓遞) 更多	-	2020-12-01
				TriGrid Delivery System (TDS)+HTNV/PUUV DNA vaccine (Vaccine at 1.0 mg)	膚積鏇醖構顧簾鏇夢構(衊艱餘簾築選積壓壓選) = 鏇鹽壓蓋製鹹鑰願鹽襯築獵網鹽艱廠壓選膚廠 (膚艱積齋範積蓋獵窪獵, 顧獵夢範獵願鏇鏇衊衊 ~ 積廠窪醖醖衊窪鬱顧鹽) 更多